Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118624
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:
The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Tumors Neoplasms, Breast Cancer of the Breast Human Mammary Carcinoma Drug: Pralatrexate Injection Dietary Supplement: Vitamin B12 Dietary Supplement: Folic Acid Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer
Study Start Date : March 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Drug: Pralatrexate Injection

    Intravenous (IV) push administration over 3-5 minutes.

    Initial dose: 190 mg/m2

    Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.

    Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.

    Other Names:
    • Pralatrexate
    • PDX
    • (RS)-10-propargyl-10-deazaaminopterin
    Dietary Supplement: Vitamin B12

    1 mg intramuscular injection

    Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate.

    Other Name: Cyanocobalamin
    Dietary Supplement: Folic Acid

    1.0-1.25 mg orally

    Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate.

    Other Names:
    • Vitamin B9
    • Folate
    • Folacin

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ]
    Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ]
    One patient has a PR as response and duration of response was provided for that patient.

  2. Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate. ]
    Number of days from first dose of pralatrexate to death.

  3. Incidence of Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal). ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HER-2 negative advanced or metastatic breast cancer
  • Disease has become worse after at least 1 prior chemotherapy regimen for advanced or metastatic disease
  • Advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen, or resistant to taxanes and for whom further anthracycline therapy is not indicated
  • Patients with controlled brain metastases must have finished receiving radiation therapy and if on corticosteroids, be on a stable or tapering dose of ≤ 10 mg/day of prednisone or equivalent for at least 28 days prior to study entry
  • Measurable disease
  • Female 18 years of age or older
  • Performance status less than or equal to 2
  • Life expectancy of more than 3 months
  • Blood, liver and kidney laboratory test results that meet protocol requirements
  • Patients must have a negative serum pregnancy test within 14 days before enrollment and agree to use medically acceptable and effective birth control from enrollment until at least 30 days after the last dose of pralatrexate. Patients who are postmenopausal for at least 1 year (more than 12 months since last menses) or are surgically sterilized do not require this test.
  • Willing to attend visits for repeat dosing and follow up
  • Give written informed consent

Exclusion Criteria:

  • Patients with only bone metastasis
  • Patients with a single metastatic site without histological proof that the lesion is metastatic breast cancer
  • Patients with inflammatory breast cancer
  • Treatment with systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, except for the following:

    • Bisphosphonates, if ongoing
    • Prior treatment with methotrexate
    • Prior treatment with anti-angiogenics within 6 months prior to enrollment
  • Have received more than 2 prior chemotherapy regimens (more than 3 if one of the treatments was neoadjuvant or adjuvant chemotherapy)
  • Have previously received pralatrexate
  • Have received more than the allowed maximum total dose of anthracycline
  • Prior radiation therapy on more than 30% of bone marrow reserve or prior bone marrow/stem cell transplantation
  • Congestive heart failure Class III/IV
  • Uncontrolled hypertension (high blood pressure)
  • Active infection or any serious medical condition, which would impair the ability of the patient to receive protocol treatment
  • Females who are pregnant or breastfeeding
  • Major surgery within 14 days of enrollment
  • Another active cancer in addition to advanced or metastatic breast cancer, except well treated in situ cervical cancer and basal cell skin cancer
  • Dementia or other altered mental status that would prevent the patient from understanding and giving informed consent or limit her ability to follow the study requirements
  • Patients who are human immunodeficiency virus (HIV)-positive and have a CD4 count of less than 100 mm3 or detectable viral load within past 3 months and is receiving anti-retroviral therapy
  • Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) who have a detectable viral load or immunological evidence of chronic active disease or receiving/requiring antiviral therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118624

United States, Oregon
Providence Cancer Center
Portland, Oregon, United States, 97213
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Czech Republic
Fakultní nemocnice Olomouc
Olomouc, Czech Republic, 775 20
Multiscan, s.r.o.
Pardubice, Czech Republic, 532 03
Fakultní nemocnice Královské Vinohrady - FNKV
Praha, Czech Republic, 100 34
Centre Lutte Contre le Cancer Val d'Aurelle (CRLC)
Montpellier, Cedex 5, France, 34298
Centre Régional de Lutte Contre le Cancer Alexis Vautrin
Vandoeuvre, les Nancy Cedex, France, 54511
Centre Georges François Leclerc
Dijon Cedex, France, 21079
Centre Léon Bérard
Lyon Cedex, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273
Institut Jean-Godinot
Reims Cedex 09, France, 51056
University of Debrecen Medical and Health Science Center
Debrecen, Hajdú-Bihar, Hungary, 4032
Semmelweis University Budapest
Budapest, Hungary, H-1082
National Health Centre of Hungary
Budapest, Hungary, H-1145
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Study Director: Garry Weems, PharmD Spectrum Pharmaceuticals, Inc

Responsible Party: Spectrum Pharmaceuticals, Inc Identifier: NCT01118624     History of Changes
Other Study ID Numbers: PDX-014
2008-006425-14 ( EudraCT Number )
First Posted: May 7, 2010    Key Record Dates
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014
Last Verified: May 2014

Keywords provided by Spectrum Pharmaceuticals, Inc:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Folic Acid
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents